Tag: TAVR

Edwards Lifesciences Comments on TAVR National Coverage Decision

IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today issued the following statement in response to the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) released by the Centers for Medicare & Medicaid Services (CMS):“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary Heart Team. Aortic stenosis is a serious, pro

Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World’s First Fully Recoverable Self-Expanding Dry-Valve TAVR System

The PREVAILS study, now fully enrolled, marks a critical step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system HANGZHOU, China, July 23, 2026 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (02500.HK) today announced that patient enrollment…

German Medtech Protembis Gets €20 Million EIB Backing for Technology to Protect Brain During Heart Treatment

July 30, 2024 01:00 AM Eastern Daylight Time LUXEMBOURG & AACHEN, Germany–(BUSINESS WIRE)–The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments. “This agreement demonstrates our commitment […]

Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability

NYON, Switzerland–(BUSINESS WIRE)–Edwards Lifesciences today announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s breakthrough RESILIA tissue technology, designed to extend the valve’s durability.* Edwards’ SAPIEN 3 Ultra RESILIA valve recently received CE Mark† for use in patients with […]

Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access DUBLIN, March 27, 2024 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and…